BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 9088179 · Received September 19, 2019

    Report

    Report Number
    1820334-2019-02376
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Report Date
    December 11, 2019
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON COMPLETION OF THE INVESTIGATION THIS FILE HAS BEEN REASSESSED. BASED ON THE ORIGINAL USERS REPORT OF ¿DR. TRIED TO DEPLOY¿INSIDE CATHETER¿IT WAS VERY TIGHT AND COIL DID NOT DEPLOY¿ THE INVESTIGATION CONCLUSION IS "COIL LODGING IN CATHETER." THERE HAS NOT BEEN A PRECEDENT SETTING EVENT WHERE COIL LODGING IN CATHETER HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THEREFORE, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION AS THERE IS NO INDICATION OF THE MALFUNCTION LEADING TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: RETRACTA DETACHABLE EMBOLIZATION COIL. DATE OF EVENT: (B)(6) 2018. PMA/510(K) #: K151676. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A RETRACTA DETACHABLE EMBOLIZATION COIL WAS USED IN AN UNKNOWN PATIENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO DEPLOY THE COIL SUCCESSFULLY THROUGH THE CATHETER. NO ADDITIONAL PROCEDURES WERE REPORTED FOR THIS INCIDENT. ADDITIONAL DETAILS REGARDING THE EVENT AND PATIENT OUTCOME ARE CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879425 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1